THE EU HAS announced proposed laws to assist the free flow of medicines from Britain into Northern Ireland, in a move it said would create momentum to resolve other disputes over Brexit’s Irish Sea border.

European Commission vice-president Maros Sefcovic announced the legislative proposals in Brussels earlier today.

The move has been welcomed by Foreign Affairs Minister Simon Coveney.

UK Brexit Minister David Frost said London would look “positively” at the EU proposals but he expressed disappointment that solutions to wider issues linked to the Northern Ireland Protocol had not yet been resolved.

He said there was an urgent need to resolve the disputes on issues such as customs paperwork, agri-food checks and the oversight role of the European Court of Justice (ECJ) in the new year.

Frost reiterated the UK’s threat to suspend operation of parts of the protocol – by triggering its Article 16 mechanism – if an agreement cannot be found next year.

I have spoken to @MarosSefcovic today and I have now issued a statement on the state of play in the talks on the Northern Ireland Protocol. The negotiations will resume early in the New Year.

The full text is here: https://t.co/rhnWL9Dvje pic.twitter.com/g2Am1F3SYr

— David Frost (@DavidGHFrost) December 17, 2021

DUP leader Jeffrey Donaldson has welcomed the announcement, but said it still left “significant problems for our constituents”.

“It is shocking that in the middle of a pandemic there is uncertainty over our access to medicines because of the NI Protocol,” he said.

Donaldson said Brussels should have no role in deciding Northern Ireland’s access to medications, adding that this was “another blatant breach” of the Good Friday Agreement.

“A foreign power should have no role in dictating to this part of the United Kingdom whether we can access medicines at the same time as the rest of the United Kingdom. Our constituents should be able to access the same drugs at the same time as the rest of the United Kingdom,” he said.

“We are seeking meetings with medicine suppliers to gauge the impact of this decision but given the EU still seeks to retain an element of control over medicines we expect the latest announcement by the EU to still leave significant problems for our constituents.”

The issues surrounding medicines stem from the outworking of the regulatory differences the protocol has created between Northern Ireland and the rest of the UK.

Under the terms of the protocol, which was agreed as part of the Brexit divorce deal to ensure a free-flowing border on the island of Ireland, Northern Ireland remains covered by the EU’s pharmaceutical regulations.

As Northern Ireland receives most of its medicines from suppliers in Britain, there had been concerns that their movement could be impeded when a grace period expires.

Grace period

That grace period was originally due to end in January but in the autumn the UK extended it unilaterally – along with other temporary exemptions associated with the protocol – pending efforts to find negotiated solutions to the issues.

The unilateral EU move to change its laws would enable the continued movement of medicines between Britain and Northern Ireland without the restrictions that would have applied under the original terms of the protocol.

Sefcovic said: “During my visit to Northern Ireland in September I promised to do whatever it takes to ensure a long-lasting solution on medicines, all the more so in the light of the current pandemic.

“I kept my word and today the Commission is delivering in the form of a legislative proposal ensuring that everyone in Northern Ireland has access to the same medicines at the same time as in the rest of the United Kingdom.”

Sefcovic said the proposed legislation covers both generic medicines and innovative new medicines, such as those for cancer treatment.

“In a nutshell this will be possible because all the regulatory functions of pharmaceutical companies supplying medicines from Great Britain to Northern Ireland can remain in the UK, while no additional batch testing, manufacturing and licence authorisation or separate packaging is required,” he said.

Sefcovic added: “I am confident that this is an important milestone and that our proposals will deliver on the objectives.

“On the one hand, they answer all concerns raised by stakeholders during our extensive outreach and at the same time we have engaged intensively with the UK Government to reach an appropriate solution.

“I’m convinced that the issue of medicines show that the protocol has the flexibility to work on the grounds.

“Therefore, we must carry this momentum into the other areas of discussion.

“The EU’s objective remains the same – to jointly identify durable solutions to ease the flow of goods between Great Britain and Northern Ireland. This covers both customs and the movement of sanitary and phytosanitary goods.”

The legislation will need to be ratified by both the European Council and the European Parliament before coming into operation

Protocol talks are set to resume in January when efforts will intensify to resolve the areas of dispute.

🆕 I promised to do whatever it takes to ensure the continued supply of medicines to Northern Ireland. We're now turning this genuine commitment to the people of NI into a lasting solution.

The Protocol on IE/NI has the flexibility to work on the ground.https://t.co/lMHYrtpK49 pic.twitter.com/QL9NXf6vnP

— Maroš Šefčovič🇪🇺 (@MarosSefcovic) December 17, 2021

Sefcovic said he hoped there would be a “gear change” in the wider negotiations with the UK on protocol issues next month.

“Today is a further demonstration of the EU’s unwavering commitment to stability and predictability for citizens and businesses in Northern Ireland and I urge the UK Government to reciprocate our efforts,” he said.

“The EU and the UK are partners with shared values and shared global challenges so it is time to change gear and bring our partnership to the level on which it belongs.”

European Court of Justice

One of the thorniest remaining issues is the oversight role of the ECJ.

The UK Government has previously insisted the total removal of the ECJ’s function was a red line, while the EU made clear Northern Ireland could not retain unfettered access to the single market without the ECJ overseeing matters of EU law.

It remains unclear whether a compromise position can be reached,  potentially one that could see a more limited role for the ECJ – confined to only EU law matters – with an independent mechanism dealing with wider arbitration issues.

While acknowledging the EU move on medicines, David Frost said there had been “much less progress in other areas”.

“Overall, with the potential exception of medicines, I do not believe that the negotiations are yet close to delivering outcomes which can genuinely solve the problems presented by the protocol,” he said

The Brexit minister said the UK had been prepared to consider an “interim agreement” on the outstanding issues pending a “comprehensive solution” being reached.

He said even an interim agreement had not been possible at this point.

“It is disappointing that it has not been possible to reach either a comprehensive or worthwhile interim agreement this year,” he said.

“A solution needs to be found urgently early next year. For as long as there is no agreed solution, we remain ready to use the Article 16 safeguard mechanism if that is the only way to protect the prosperity and stability of Northern Ireland and its people.”

The proposed EU law change on medicines would allow GB-based pharma suppliers to maintain their current regulatory arrangements.

It would mean companies in GB could continue to act as a hub for the supply of generic medicines to Northern Ireland, without the need to establish bases in the region.

The proposals would also apply to other small markets which use British medicines, including Ireland, Malta and Cyprus.

Irish Government response

Minister for Foreign Affairs and Minister for Defence, Simon Coveney has welcomed the update today by the EU and the UK on the ongoing talks on the implementation of the Protocol on Ireland/Northern Ireland.

“Access to medicines has been at the top of my agenda. The plan announced today turns commitment into solutions.

“By ensuring the continued long-term supply of medicines from Great Britain to Northern Ireland and in addressing other supply issues for Ireland, it provides reassurance to people across the island that they will continue to have access to the medicines they need.

“I hope that this solution on medicines can act as a catalyst for solving the other Protocol issues early in the new year,” he said.

Coveney said the Irish Government were supportive of EU and British Government efforts to continue talks on the Northern Ireland protocol.

“I firmly believe the Protocol will work, if we allow it, with flexibility and pragmatism. A positive outcome to the current talks remains our key objective. I welcome the fact that the EU and the UK have agreed on the importance of continuing talks in the New Year.

“This is the best way to bring about substantive progress and find durable solutions to the practical problems faced by people and business in Northern Ireland.

“Brexit has been one of the dominant issues on my agenda this year and I spent a lot of time listening to stakeholders in Northern Ireland in order to understand the genuine challenges they face. Commission Vice President Maros Sefcovic has done likewise. Ireland continues to strongly support his solution-driven approach,” he said. 

With reporting from the Press Association.